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Aptima HCV Quant Dx Assay (US-IVD)

The Aptima HCV Quant Dx assay is FDA approved US-IVD for the detection and quantitation of hepatitis C virus (HCV) on the fully automated Panther system. This assay features:

  • Ultrasensitive, highly precise performance over a wide linear range, across all major genotypes.

  • Validated sample dilution protocols allow you to run samples with as little as 240µL.

  • Minimize operator hands-on time with true sample-to-result automation on the Panther system.

About

The Aptima HCV Quant Dx assay is a an in vitro nucleic acid amplification test (NAAT) for the detection and quantitation of HCV RNA in fresh and frozen human serum and plasma on the fully automated Panther system. The assay is indicated for use as an aid in the diagnosis of active HCV infection and for use as an aid in the management of HCV-infected patients undergoing HCV antiviral drug therapy.

The FDA-approved US-IVD Aptima HCV Quant Dx assay allows you to:

  • Streamline and simplify HCV testing within your lab with the versatility of a single assay for both confirmation of active infection and patient management.

  • Quantify HCV RNA—across major genotypes 1-6—with ultrasensitivity and high precision over a wide linear range.

  • Strategic design with 3 levels of protection:

    • Redundant target capture oligos to protect against potential mutations.

    • Longer oligos for extra protection against single base mismatches.

    • Multiple amplification primers for broad genotype coverage.

Diagnostic and Confirmatory Testing of HCV

The Aptima HCV Quant Dx assay is indicated for use as an aid in the diagnosis of HCV infection. The assay can be used to confirm active HCV infection in patients with a positive HCV antibody result. Detection of HCV RNA indicates that the virus is replicating and, therefore, is evidence of active infection.

Management of HCV Infected Patients

The Aptima HCV Quant Dx assay is indicated for use as an aid in the management of HCV infected patients undergoing HCV antiviral drug therapy.The assay measures HCV RNA levels at baseline, during treatment and after treatment to determine sustained virological response (SVR).The results from the Aptima HCV Quant Dx assay must be interpreted within the context of all relevant clinical and laboratory findings.

The Aptima HCV Quant Dx assay is not intended for use as a screening test for the presence of HCV in blood or blood products.

Performance Data
Ultrasensitivity for Treatment Management

The Aptima HCV Quant Dx assay’s Limit of Detection (LoD) is 3.9 IU/mL in plasma and 3.4 IU/mL in serum.

(All tables and figures in this section can be found in the Aptima HCV Quant Dx Assay Package Insert.)

LoD of the Aptima HCV Quant Dx Assay Using the WHO 2nd International Standard

The LoD of the assay is defined as the concentration of HCV RNA that is detected at 95% or greater probability according to CLSI EP17-A2.18

The LoD was determined by testing panels of the WHO 2nd International Standard for Hepatitis C Virus RNA (NIBSC 96/798 genotype 1) diluted in HCV negative human EDTA plasma and serum. Each dilution had 36 replicates which were tested with each of 3 reagent lots for a minimum of 108 replicates per dilution. Probit analysis was performed to generate the predicted detection limits. The LoD values are the results from the reagent lot with the highest predicted detection limit. The 95% LoD for the Aptima HCV Quant Dx assay using the WHO 2nd International Standard is 3.9 IU/mL for plasma and 3.4 IU/mL for serum.

LoD Across HCV Genotypes 1-6

 

Lower Limit of Quantitation (LLoQ)

The LLoQ of the Aptima HCV Quant Dx assay is 10 IU/mL.

Determination of LLoQ Across Genotypes in Plasma

 

Determination of LLoQ Across Genotypes in Serum

 

Confidence in Performance Across a Broad Linear Range

The linear range was established by testing panels of HCV Armored RNA (aRNA) diluted in HCV negative human plasma and serum according to CLSI EP06-A.19.  Panels ranged in concentration from 1.0 log10 IU/mL to 8.2 log10 IU/mL. The Aptima HCV Quant Dx assay demonstrated linearity across the range tested, with an upper limit of quantitation (ULoQ) of 8.0 log10 IU/mL.

Linearity in Plasma and Serum

 
Linear Range and Linearity (Plasma)

 

Linear Range and Linearity (Serum)

 

Reliable Quantitation

The Aptima HCV Quant Dx assay precision panel was built by diluting HCV-positive clinical plasma and HCV aRNA into HCV-negative clinical plasma (the two highest panel members were aRNA). Seven positive panel members spanned the range of the assay (1.86 log10 IU/mL to 7.68 log10 IU/mL), and were tested in 3 replicates per run by 1 operator, using 1 pilot lot of reagents on 1 Panther system over 21 test days, 2 runs a day. Total variability was ≤ 0.14 across all panel members, primarily due to intra-run variability (i.e., random error).

Precision of the Aptima HCV Quant Dx Assay

 
Sample Dilution Using Aptima Specimen Diluent

To assess the detection accuracy of HCV RNA in samples diluted with Aptima Specimen Diluent plasma or serum, 5 naturally infected plasma specimens and 5 naturally infected serum specimens, along with 10 specimens each of HCV negative plasma and serum spiked with HCV aRNA targeting above the ULoQ, 8 log10 IU/mL at 8.30 log10 IU/mL were tested in triplicate. A 1:100 dilution was performed with 1 part sample and 99 parts Aptima Specimen Diluent just prior to testing. Testing was performed using 1 lot of assay reagents on 1 Panther system with 2 Aptima Specimen Diluent lots. The difference between the neat and diluted test results was calculated for each sample.

Plasma Specimen 1:100 Dilution Matrix Comparison Summary of Log10 IU/mL

 

Serum Specimen 1:100 Dilution Matrix Comparison Summary of Log10 IU/mL

 

 

Glossary

HCV: Hepatitis C Virus

RNA: ribonucleic acid

References

Aptima HCV Quant Dx Assay [package insert]. AW-14496, Rev. 001. San Diego, CA: Hologic, Inc.; 2017.